Beware of New Drugs! They may not have been tried before!

It is well known that free passage to international medical conferences, free lodging and boarding in a foreign country and expensive gifts are some of the items from a long list of temptations offered by the drug companies to entice Doctors and medical practitioners to presribe their products to patients. Some of the black sheep Doctors of the clique, on condition of being anonymous, sometime describe in details, how anything, medically significant, is ever discussed at these international conferences. That is however besides the point. Enticements offered by these drug companies are essentially a part of sales promotion work. I do not know whether it is ethically correct or wrong, but that is how the medicine business works world wide.

A news story releassed today reveals a much more serious plan, put to work by some drug companies, which has the dimensions of a major scam. In India, the topmost authority, who has mandatory control over all drugs related issues is known as Drug Controller General of India (DCGI). Which drugs are to be allowed? Which are to be banned? At what price the drugs should be sold? Are some of the issues that need DCGI clearance. In case of new drugs, before allowing them to be released in the market, DCGI procedure specifies that scientific recommendations from medicinal experts in the field regarding effectiveness of drugs and if any side effects are observed, need to be submitted. India's Central Drugs Standard Control Organization (CDSCO), considers such scientific recommendation and the endorsement by experts absolutely necessary before the effectiveness of a drug can be trusted. CDSCO would consider to allow the drug to be released in the market only when such recommendations are received. Since CDSCO do not have medical practitioners on their staff roll, they consider it aboslutely a must that scientific recommendations are given by medical experts in the field.

This is all fine on paper. But what exactly is happening in practice? Indian parliament has a standing committee that overlooks the matters concerning health and family welfare. This committee recently tabled a report on functioning of Central Drugs Standard Control Organization (CDSCO). This scathing report says, “ there is ample evidence to show that several scientific recommendations submitted to the CDSCO to push a drug into market were actually written by invisible hands of drug companies themselves and experts merely obliged by putting their signatures." This committee found to it's horror "expert advise and letters of recommendation" from these experts read the same - word by word - and were submitted on the same day.” Committee report gives number of examples of this practice followed by drug companies, obviously in connivance with CDSCO.

For a drug named as Clevudine (Phamasset Inc), three professors of medicine - from AIIMS, KBN Medical College, Gulbarga and RG Kar Medical College, Kolkata - located at places which are thousands of miles apart from each other, have given a word for word identical letters of recommendation. In identical language they recommend that the company may be permitted to market the drug without conducting mandatory clinical trials in India.

A medicine called Sertindole, (an anti-psychotic drug by Lundbeck), three experts located at three different places (head of the department of psychiatry of Stanley Medical College, Chennai, doctor from Psychiatric Nursing Home, Ahmedabad and HoD psychiatry of LTM Medical College, Mumbai) have given letters of recommendation in nearly word-by-word, identical language.

For Pirfenidone (made by Cipla), professor of pulmonary medicine, AIIMS; a chest physician from Lilavati Hospital, Mumbai; an additional professor of pulmonary medicine from PGI, Chandigarh and a pulmonologist of Yashoda Hospital, Secunderabad have all given their recommendations on same daywere all received exactly on the same day and have adjacent receipt number of DCGI.

For Rivaroxaban , a drug for prevention of clotting, manufactured by Bayer, Prof of orthopedics, AIIMS; consultant at Dayanand Medical College, Ludhiana and professor of orthopedics from St Johns Medical College, Bangalore, have all given recommendations, which are ditto copies of each other.

In the case of Doxofylline, an anti-asthmatic drug, Prof of medicine of MGM Medical College, Indore and a consultant from Indraprastha Apollo Hospital, New Delhi have given recommendations which are also word-by-word identical.

For Nimesulide injection, HOD of medicine, Government Medical College, Aurangabad and senior consultant orthopedic surgeon of Indraprastha Apollo Hospital, Delhi, have goven letters of opinion which seem to have reached DCGI exactly on the same day and have receipt numbers adjacent to each other.

In case of Ademetionine, doctors belonging to Lokmanya Tilak Medical College, Mumbai; Medical College, Thiruvananthapuram; IPGMER Kolkata and chairman and chief of hepatology of Sir Ganga Ram Hospital, Delhi have all given letters of recommendation with similar comments.

The case of fixed dose combination of Aaceclofenac with Drotaverine, which is not permitted in any developed country of North America, Europe or Australasia, is extremely curious. Here an official from CDSCO office wrote to the manufacture 'Themis Medicare Ltd.' that the company should select the experts and get their opinions and then deliver them to CDSCO.

The parliamentary committee, very rightly has concluded that "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts." From this 'modus operandi' of the drug companies becomes crystal clear. For any new medicines that these companies desire to market in India, they just create a research report or a letter of recommendation, get the signature of any Doctor in the country on the dotted line, who might not even have prescribed the medicine before, Collect such reports from four corners of the country, creating an impression that drug has undergone extensive clinical trials over a wide area and complete the formality of submission of documents to CDSCO.

The CDSCO, on their part, instead of being controllers, have degraded themselves as facilitators. They are, like every other bureaucratic organization of the Government, plagued by the ever present evil of corruption. But why should all these eminent Doctors and Medical Practitioners fall easy pray to vilely ways of drug companies? is a question that pains my mind. But is their really a difference between a Doctor enjoying free hospitality of a drug company in a foreign land, under pretext of attending a medical conference and the Doctors, who have signed on the dotted line on a letter of recommendation of a drug, which has been never prescribed by them. It is a major scam that in these both cases, Doctors, instead of giving sound scientific evidence, are working for the drug companies.

10 May 2012